(30 days)
The Electrosurgery Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures include the following: General Surgery: cholecystectomy, lysis of adhesions, upper GI, GI (other), splenectomy, thyroidectomy, herniorrhaphy, breast biopsy, bowel resection, pelvic adhesiolysis, removal of lesions, removal of polyps, tumor biopsy. Gynecological Surgery: lysis of adhesions, hysterectomy, salpingo-oophorectomy, burch colposuspension, myomectomy, endometriosis, ovariohysterectomy, removal of tumors.
The Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications.
The provided document is a 510(k) summary for ArthroCare Electrosurgery Wands. It discusses a special 510(k) submission for modifications to a previously cleared device (K014222). The key aspect of this submission is that the modified specifications, materials, and labeling are not substantial and do not significantly affect the safety or efficacy of the devices, and thus the device is considered substantially equivalent to its predicate.
Crucially, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical data analysis, such as sensitivity, specificity, or accuracy metrics often associated with AI/ML devices.
This document is a regulatory submission for an electrosurgical device, not an AI/ML diagnostic tool. Therefore, the questions related to clinical study design for AI/ML devices (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable to the information contained within this 510(k) summary.
The summary states: "The Electrosurgery System modified Wands, as described in this submission, are substantially equivalent to the predicate, unmodified Wands. The proposed modifications in dimensional and performance specifications, materials, and labeling are not substantial and do not significantly affect the safety or efficacy of the devices." This statement serves as the "proof" that the device meets acceptance criteria, implying that it continues to perform as safely and effectively as the predicate device because the changes are not substantial.
Therefore, I cannot populate the table or answer most of the questions as the document does not provide this type of information.
Here's what I can infer from the document regarding the general nature of this submission:
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A table of acceptance criteria and the reported device performance:
The document asserts "substantial equivalence" to a predicate device (K014222) due to "modifications in dimensional and performance specifications, materials, and labeling [that] are not substantial and do not significantly affect the safety or efficacy of the devices." This implies that the 'acceptance criteria' are met by demonstrating that the modified device performs identically or insignificantly differently from the predicate device, whose performance would have been established during its original clearance. No specific quantitative performance metrics (e.g., in terms of cutting efficiency, coagulation time, tissue damage) or acceptance thresholds for these metrics are provided in this summary. -
Sample sizes used for the test set and the data provenance: Not applicable. This document does not describe a clinical study in the context of an AI/ML device to establish performance metrics against a test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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Adjudication method for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
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The type of ground truth used: Not applicable.
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The sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided text is a regulatory clearance document for an electrosurgical device based on substantial equivalence, not a performance study report for an AI/ML medical device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.